Hearth Record

PowerLoc MAX Power Injectable Infusion Port Access Kit

Medical device recall Z-2662-2020. Published in FDA’s Enforcement Report on Jul 29, 2020.

FDA’s own record, on accessdata.fda.gov

No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.

The short answer

Published in FDA’s Enforcement Report on Jul 29, 2020. Copied from openFDA on Oct 20, 2026.

Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.

How serious is it, by FDA’s class?

Class II, the middle of FDA’s three classes.

“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”

openFDA, in plain words, its enforcement report fields.

“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

FDA’s rule, 21 CFR 7.3(m)(2), eCFR.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

PowerLoc MAX Power Injectable Infusion Port Access Kit; Catalog Numbers 2131910 (UDI 00801741044151), 2131915 (UDI 00801741044168), 2131975 (UDI 00801741044175), 2132010 (UDI 00801741044151), 2132015 (UDI 00801741044199), 2132075 (UDI 00801741044205), 2132210 (UDI 00801741044212), 2132275 (UDI 00801741044236), 2141910 (UDI 00801741044243), 2141915 (UDI 00801741044250), 2141975 (UDI 00801741044267), 2142010 (UDI 00801741044274), 2142015 (UDI 00801741044281), 2142075 (UDI 00801741044298), 2142210 (UDI 00801741044304), 2142215 (UDI 00801741044311), 2142275 (UDI 00801741044328)

5,296,132 total, in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

Catalog Numbers 2131910 (UDI 00801741044151), 2131915 (UDI 00801741044168), 2131975 (UDI 00801741044175), 2132010 (UDI 00801741044151), 2132015 (UDI 00801741044199), 2132075 (UDI 00801741044205), 2132210 (UDI 00801741044212), 2132275 (UDI…

Every code shown here, 1,618 characters

Catalog Numbers 2131910 (UDI 00801741044151), 2131915 (UDI 00801741044168), 2131975 (UDI 00801741044175), 2132010 (UDI 00801741044151), 2132015 (UDI 00801741044199), 2132075 (UDI 00801741044205), 2132210 (UDI 00801741044212), 2132275 (UDI 00801741044236), 2141910 (UDI 00801741044243), 2141915 (UDI 00801741044250), 2141975 (UDI 00801741044267), 2142010 (UDI 00801741044274), 2142015 (UDI 00801741044281), 2142075 (UDI 00801741044298), 2142210 (UDI 00801741044304), 2142215 (UDI 00801741044311), 2142275 (UDI 00801741044328). Lot Numbers: REDW3798 REDY2866 REDZ1719 REEN3137 REEP0951 REEQ2684 REEQ4092 REER1229 REEQ0664 REEQ1649 REER0459 REDZ1818 REEP3049 REDW1092 REDX3754 REDY1682 REDY2971 REDY3530 REDZ1070 REEN3271 REEN4480 REEP0992 REEP3957 REEQ1647 REEQ2724 REEQ4093 REER1266 REDY3719 REEN1270 REEP0952 REEQ0684 REEQ2676 REEQ4054 REER0460 REDT2879 REDU2256 REDU3371 REDU4487 REDV1088 REDV2972 REDV3470 REDW0402 REDW1087 REDX1518 REDY1804 REDY2867 REDY3531 REDZ1069 REEN1104 REEN4481 REEP0953 REEP3958 REEQ0665 REEQ1650 REER0530 REEN2139 REEP4053 REER0461 REDY3720 REEQ4094 REDW3682 REDY0827 REDZ1071 REEP0994 REER0539 REEN4551 REEP0954 REEQ1648 REDW1197 REDY2972 REDZ3130 REEP0995 REEP2909 REDW0546 REDX1519 REDX4930 REDY1683 REDY2868 REDY3532 REDZ1064 REDZ1819 REEN1046 REEN2146 REEP0955 REEP3052 REEP3959 REER0462 REDZ1721 REEQ2678 REDV1236 REDW0407 REDW0550 REDX4852 REDY0773 REDY0828 REDY1684 REDY2973 REDZ1063 REDZ1072 REDZ1820 REEN1271 REEN3273 REEP0956 REEP0996 REEP1728 REEP3053 REEP4054 REEQ1664 REEQ2720 REER0540 REDW3683 REDY3721 REEN4552 REER1261 REEN3155 REDW0403 REDY1685 REDZ1722 REEP0997 REEQ0666

Source:

Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.

Where did it go?

FDA’s words for the “general area of initial distribution”: where the firm first shipped it.

Worldwide Distribution

These words name no state.

The words say it went outside the United States too.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Is it still going on?

Terminated, in FDA’s file.

“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”

openFDA, on “Terminated”, its enforcement report fields.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on Jun 19, 2020.
  • FDA classified it on Jul 18, 2020.
  • FDA’s Enforcement Report published it on Jul 29, 2020.
  • FDA terminated it on Jul 29, 2022.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Who is recalling it?

  • Becton Dickinson & Company, of Franklin Lakes, NJ.
  • Who began it, in FDA’s words: Voluntary: Firm initiated.
  • How the firm first told its customers: Letter.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

What this record can’t tell you

  • Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
  • Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
  • How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
  • Whether anyone was hurt or fell ill: the report doesn’t say.
  • How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
  • A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Source:

Hearth Record wrote these lines; the quotations are FDA’s.

Sources

  • U.S. Food and Drug Administration, Device recall enforcement reports.

    Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.

Source:

Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.

How to read a record

Four things every record does, shown on an example record made up for this guide.

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Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

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Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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